The Food and Drug Administration (FDA) has approved updated labeling for Amzeeq® (minocycline; Vyne Therapeutics) topical foam 4% to include new information related to antimicrobial resistance.
Amzeeq is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older. Results from an antimicrobial characterization study showed that Propionibacterium acnes (renamed Cutibacterium acnes) strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies being less than 10−8 (or 1 in 100 million) at 2 to 16 times the minimum inhibitory concentration. The label also states that minocycline is active in vitro against most isolates of P. acnes.
“The risk of antimicrobial resistance is a primary concern for dermatologists or, indeed, any routine prescriber of antibiotics,” said David Domzalski, CEO of Vyne. “We are pleased that the inclusion of this valuable additional information for Amzeeq will support prescribers in making informed decisions on both their choice of antibiotic and administration route when selecting a treatment for acne.”
Amzeeq topical foam is supplied in 30g aerosol cans; each gram contains 40mg of minocycline equivalent to 43mg of minocycline HCl.
1. Vyne Therapeutics announces FDA approval of Amzeeq® (minocycline) label update. [press release]. Bridgewater, NJ: Vyne Therapeutics; February 1, 2021.
2. Amzeeq® [package insert]. Bridgewater, NJ: Vyne Therapeutics; 2021.
This article originally appeared on MPR